Clinical trial

4XL Study - Obesity Surgery in Adolescence

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT00923819

Active, not recruitingNot applicableInterventional

What this study is about

The purpose of this study on adolescents between 13 and 18 years of age with morbid obesity is to determine whether surgical treatment gives more health benefits than standard conservative treatment, and if laparoscopic gastric bypass is a method with high safety and a low complication rate.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age13 Years to 18 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Morbid

Full registry criteria

Inclusion Criteria: * Between 13 and 18 years of age at inclusion * Tanner stage 4-5 * BMI \> 40 kg/m2 or BMI \> 35 with at least one comorbidity (type 2-diabetes, obstructive sleep apnea, serious hypertension or cerebral pseudotumor) * At least one year multidisciplinary treatment completed Exclusion Criteria: * Tanner stage \< 4 * Substantial risk for lack of compliance * Obesity syndrome (e.g., Prader Willi syndrome) * Obesity related to brain damage * Serious general disease * Monogenic obesity

Treatments and study arms

Laparoscopic gastric bypass

Procedure

Patients are referred to Morbid Obesity Center from Vestfold Hospital Trust and other hospitals in Norway. The procedure will take place at Morbid Obesity Center, Vestfold Hospital Trust.

Standard conservative treatment

Behavioral

Participants from Child Obesity Registry who undergoes conservative treatment at Morbid Obesity Center, Vestfold Hospital Trust.

Primary outcomes

BMI and weight lossBaseline, Year 1, 2, 5, 10

Surgical or standard conservative treatment

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority🇳🇴 Tønsberg, Norway

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